中国中药杂志

2019, v.44(24) 5303-5312

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茵栀黄口服液治疗新生儿黄疸的系统评价与Meta分析
Systematic review and Meta-analysis of effect of Yinzhihuang Oral Liquid in treatment of neonatal jaundice

田彩蝶;吕健;谢雁鸣;孙梦华;
TIAN Cai-die;LYU Jian;XIE Yan-ming;SUN Meng-hua;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Xiyuan Hospital,China Academy of Chinese Medical Sciences;

摘要(Abstract):

对茵栀黄口服液治疗新生儿黄疸的有效性和安全性进行系统评价和Meta分析。系统检索电子数据库CNKI,WanFang,VIP,Sino Med,PubMed,Medline,Cochrane Library,检索时间为建库至2019年4月,筛选出茵栀黄口服液治疗新生儿黄疸的随机对照试验(randomized controlled trials,RCTs),对符合纳入标准的文献进行数据提取,并应用Cochrane评价手册中的风险偏倚评估工具对纳入文献的质量进行评价,最后通过Rev Man 5. 3软件对其效应量进行Meta分析。共纳入30项研究,总样本量3 923例,试验组1 940例,对照组1 983例。Meta分析结果提示:试验组总有效率(RR=1. 22,95%CI [1. 18,1. 26],P<0. 000 01)、治疗后总胆红素水平(MD=-38. 78,95%CI[-48. 38,-29. 18],P <0. 000 01)、退黄时间(MD=-1. 76,95%CI[-2. 10,-1. 41],P<0. 000 01)、日均胆红素下降值(MD=11. 67,95%CI[8. 89,14. 45],P<0. 000 01),均显著优于对照组,差异均有统计学意义;不良反应方面有9项研究报告,主要为腹泻、呕吐、发热、皮疹等症状,不影响治疗效果。茵栀黄口服液联合常规治疗新生儿黄疸效果较好,不良反应轻微,优于单纯常规治疗,但鉴于纳入研究质量普遍不高,影响结论的可靠性,建议以后开展更多大样本、多中心、经科学设计、严格实施的高质量随机对照试验来验证茵栀黄口服液治疗新生儿黄疸的疗效和安全性。
To systematically review effectiveness and safety of Yinzhihuang Oral Liquid in the treatment of neonatal jaundice. A systematic retrieval was performed throughout China National Knowledge Infrastructure( CNKI),Wan Fang,VIP,Sino Med and PubMed,Medline,Cochrane Library databases from the establishment to April 2019. Randomized controlled trials of Yinzhihuang Oral Liquid in treatment of neonatal hyperbilirubinemia were retrieved. Clinical studies in line with the inclusion criteria were involved for data extraction,and the quality of the included literatures was evaluated by the risk bias assessment tool in the Cochrane review manual. Finally,Meta-analysis was performed by Rev Man 5.3 software. A total of 30 studies were involved,involving 3 923 child patients,including1 940 in observation group and 1 983 in control group. According to the results of Meta-analysis,the total effective rate( RR = 1. 22,95%CI[1. 18,1. 26],P<0. 000 01),level of TBi L after treatment( MD =-38. 78,95%CI[-48. 38,-29. 18],P<0. 000 01),time to jaundice resolution( MD =-1. 76,95% CI[-2. 10,-1. 41],P < 0. 000 01) and daily average decrease value of bilirubin( MD =11. 67,95%CI[8. 89,14. 45],P<0. 000 01) of observation group were significantly better than those of control group,with statistically significant differences. Adverse reactions were reported in nine studies,mainly including diarrhea,vomiting,fever,rash and other symptoms,which did not affect the treatment effect. The effectiveness of Yinzhihuang Oral Liquid combined with conventional therapy in treating neonatal jaundice was better than conventional therapy alone,with little adverse reactions. However,most of literatures included had a low research quality,which impacted the reliability of the conclusion. Therefore,it is suggested to conduct more largesample-size,multicenter,scientifically designed,strictly implemented high-quality randomized controlled trials in the future,in order to study the efficacy and safety of Yinzhihuang Oral Liquid in the treatment of neonatal jaundice.

关键词(KeyWords): 茵栀黄口服液;新生儿黄疸;随机对照试验;系统评价;Meta分析
Yinzhihuang Oral Liquid;neonatal jaundice;randomized controlled trials;systematic review;Meta-analysis

Abstract:

Keywords:

基金项目(Foundation): 国家重点研发计划项目(2018YFC1707400);; 中央级公益性科研院所基本业务费项目(Z0605)

作者(Author): 田彩蝶;吕健;谢雁鸣;孙梦华;
TIAN Cai-die;LYU Jian;XIE Yan-ming;SUN Meng-hua;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences;Xiyuan Hospital,China Academy of Chinese Medical Sciences;

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